. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/268 
26 July 2006 
 (06-3595) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English/ 
 French 
 
 
 
NOTIFICATION 
 
1. Member to Agreement notifying:  CANADA  
If applicable, name of local government involved:   
2. Agency responsible:  Health Canada  
3. Products covered (provide tariff item number(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where applicable):  Formulated liquid diets (ICS: 67.040)  
4. Regions or countries likely to be affected, to the extent relevant or practicable:  Not 
stated  
5. Title, language and number of p ages of the notified document:  Interim Marketing 
Authorization regarding the use of vitamin D in formulated liquid diets (Available in 
English and French;  2 pages).  
6. Description of content:   
Health Canada has received a submission to increase the maximum levels of vitamin D in 
formulated liquid diets from the current perm itted level of 400 Intern ational Units (IU) per 
1,000 kilocalories (kcal) to 800 IU per 1, 000 kcal where the recommended intake is 
2,500 kcal per day or less, and from 200 IU pe r 1,500 kcal to 400 IU per 1,500 kcal where 
the recommended intake is greater than 2,500 kcal per day.  Health Canada has completed a safety assessme nt of the proposal to increase the maximum 
amount for vitamin D in formulated liquid diets.   Evaluation of the available data supports 
the safety of these modifications.  Permitting higher levels of vitamin D in formulated liquid 
diets would assist persons relying on these pr oducts as their sole or major source of 
nutrition, in maintaining adequate vitamin D intakes.  The revised upper level would also 
benefit manufacturers by allowing the production of a single formulation for marketing in 
Canada and the United States. 
 
Therefore, Health Canada intends to recomme nd that the table of section B.24.102 of the 
Food and Drug Regulations  be amended to allow a higher maximum level of vitamin D in 
formulated liquid diets, that is, 800 IU per 1,000 kcal for recommended intake of up to 2,500 kcal per day, and 400 IU per 1,500 kcal for recommended intake of greater than 
2,500 kcal per day, including overages. G/SPS/N/CAN/268 
Page 2  
 
   As a means to improve the responsiveness of th e regulatory system, an Interim Marketing 
Authorization (IMA) is being issued to permit the immediate sale of formulated liquid diets, 
with an increased maximum level of vitami n D, as indicated above, while the regulatory 
process is undertaken to formally amend the Re gulations. A revision to this notification will 
be published at the start of the amendm ent process and Members will be given the 
opportunity at that time to submit comments on this proposed measure.  
7. Objective and rationale: [ X ] food safety,  [   ] animal health,  [   ] plant protection, 
[   ] protect humans from animal/plant pest or disease, [   ] protect territory from other damage from pests   
8. International standard, guideline or recommendation: 
[   ] Codex Alimentarius Commission,  [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention,  [ X ] None 
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:   
9. Relevant documents and language(s) in which these are available:  Canada Gazette, 
Part I, 15 July 2006, Pages 2106-2107 (A vailable in English and French)  
10. Proposed date of adoption:  Immediate for this IMA.  For the final regulation, will be stated 
in subsequent revision or addendum to this notification.  
11. Proposed date of entry into force:  Immediate for this IMA.  For the final regulation, will 
be stated in subsequent revision or addendum to this notification.  
12. Final date for comments:  This document is not for comment at this time.  A comment 
period will be provided in a revision of this notification.  
Agency or authority designated to handle comments:  [   ] National notification 
authority, [ X ] National enquiry point, or address, fax number and E-mail address (if 
available) of other body:   
13. Texts available from:  [   ] National notification authority, [ X ] National enquiry point, 
or address, fax number and E-mail address (if available) of other body:   
The electronic version of the regulat ory text can be downloaded at:  
http://canadagazette.gc.ca/partI/2006/20060715/pdf/g1-14028.pdf